Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER

Wageningen University1 site in 1 country316 target enrollmentOctober 2011

Overview

The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.

This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

May 2015

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Age 40-70 years
•Impaired fasting glucose (IFG; i.e. venous plasma glucose concentration ≥6.1 and
•≤6.9 mmol/l) during the past 5 years, according to the GP registration database OR diabetes risk score ≥7 as calculated from the Diabetes Risk Test
•Willing and able to participate in the intervention for at least 1.5 years
•Dutch speaking

•Known diabetes mellitus
•Any chronic illness that makes 1.5-years survival improbable, interferes with glucose tolerance, or makes participation in a lifestyle intervention impossible
•Patients with any severe cardiovascular disease (this also includes history of cardiac dysrhythmia), unless GP gives agreement
•Medication known to interfere with glucose tolerance
•Any mental or physical disability that will hinder participation in the lifestyle intervention
•Severe psychiatric disease
•Patients who showed bad compliance in the past
•Participation in another regular vigorous exercise and/or diet programme, i.e.:
•Intensive exercise programme: any exercise programme offered by a physiotherapist and/or patients sporting at least 3 times a week at their own initiative.
•Intensive diet programme: patients who visited a dietician at least 3 times during the last year.

Change in fasting insulin

Time Frame: Baseline, end of intervention (12 months), after follow-up (18 months)

Medication use(Baseline, end of intervention (12 months), after follow-up (18 months))
Glucose tolerance(Baseline, end of intervention (12 months), after follow-up (18 months))
Serum lipids(Baseline, end of intervention (12 months), after follow-up (18 months))
Quality of Life(Baseline, end of intervention (12 months), after follow-up (18 months))
Eating behaviour(Baseline, end of intervention (12 months), after follow-up (18 months))
Physical fitness(Baseline, end of intervention (12 months), after follow-up (18 months))
Blood pressure(Baseline, end of intervention (12 months), after follow-up (18 months))
Physical activity behaviour(Baseline, end of intervention (12 months), after follow-up (18 months))
Behavioural determinants(Baseline, end of intervention (12 months), after follow-up (18 months))
Body fatness(Baseline, end of intervention (12 months), after follow-up (18 months))
Process indicators(Baseline, end of intervention (12 months), after follow-up (18 months))